# FDA 483 - Quali Controle - December 13, 2024

Source: https://www.globalkeysolutions.net/records/483/quali-controle/c30227c9-bfa7-4f4f-a084-8f51db6a5e8c

> FDA 483 for Quali Controle on December 13, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Quali Controle
- Inspection Date: 2024-12-13
- Product Type: other
- Office Name: Office of Inspections and Investigations
- Summary: Quali Controle, a control testing laboratory in Meru, France, was cited for significant deficiencies during an FDA inspection. The inspection revealed that test methods used for analyzing samples, including those for the U.S. market, were not properly validated or verified. Additionally, the firm failed to thoroughly review out-of-specification discrepancies, with investigations either remaining open without justification or being closed without adequate corrective and preventive actions.

## Related Documents

- [483 - 2017-09-15](https://www.globalkeysolutions.net/records/483/quali-controle/7eb331d3-1868-499e-be64-a9a921eb8b79)
- [WARNING_LETTER - 2017-09-15](https://www.globalkeysolutions.net/records/warning_letter/quali-controle/22d533ce-769a-4efa-838e-f8237d86e69c)

## Related Officers

- [Consumer Safety Officer , Investigator](https://www.globalkeysolutions.net/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)

Company: https://www.globalkeysolutions.net/companies/quali-controle/19b64d1b-0417-43f9-ae30-317539756145

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8